222 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·May 21, 2025
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·June 15, 2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
FDA Enforcement
Class II
·Ongoing·Cook Inc.·December 29, 2021
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr AQ-003600 G17151; 7.0 Fr AQ-003700 G17152
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 29, 2019
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·November 27, 2024
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 27, 2019
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
FDA Enforcement
Class II
·Ongoing·Cook Medical Llc·January 24, 2024
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Enforcement
Class II
·Completed·Cook Incorporated·July 20, 2022